e10qsb
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-QSB
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2006
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o |
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TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT |
For the transition period from to
Commission file number 0-12627
MEDICAL DISCOVERIES, INC.
(Exact name of Small Business Issuer as specified in its charter)
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Utah |
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87-0407858 |
(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.) |
1388 S. Foothill Drive, #266, Salt Lake City, Utah 84108
(Address of principal executive offices)
(801) 582-9583
(Issuers telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the
Exchange Act during the past 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate
by check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act). Yes
o No þ
APPLICABLE ONLY TO CORPORATE ISSUERS:
State the number of shares outstanding of each of the issuers classes of common equity, as of the
latest practicable date: As of May 15, 2006, there were 107,922,148 shares of the issuers Common
Stock and 41,800 shares of the issuers Series A Preferred Stock outstanding.
Transitional Small Business Disclosure Format (check one): Yes o No þ
PART I
FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
The following financial statements are filed with this report:
Condensed Consolidated Balance Sheets as of March 31, 2006, (unaudited) and December 31, 2005
(audited)
Condensed Consolidated Statements of Operations for the three-month periods ended March 31, 2006
(unaudited) and March 31, 2005 (unaudited), and from inception of the development stage on November
20, 1991 through March 31, 2006 (unaudited)
Condensed Consolidated Statements of Cash Flows for the three-month periods ended March 31, 2006
(unaudited) and March 31, 2005 (unaudited), and from inception of the development stage on November
20, 1991 through March 31, 2006 (unaudited)
Notes to Unaudited Condensed Consolidated Financial Statements
- 3 -
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Condensed Consolidated Balance Sheets
(Unaudited)
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March 31, |
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December 31, |
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2006 |
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2005 |
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ASSETS |
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CURRENT ASSETS |
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Cash |
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$ |
106,589 |
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$ |
654,438 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total Current Assets |
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106,589 |
|
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|
654,438 |
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|
|
|
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|
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|
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Note receivable |
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303,475 |
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296,050 |
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Property and equipment, net |
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75,621 |
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80,635 |
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TOTAL ASSETS |
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$ |
485,685 |
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$ |
1,031,123 |
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LIABILITIES AND STOCKHOLDERS DEFICIT |
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CURRENT LIABILITIES |
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Accounts payable |
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$ |
2,425,462 |
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$ |
2,608,783 |
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Accrued interest payable |
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245,208 |
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237,836 |
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Notes payable |
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56,000 |
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56,000 |
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Convertible notes payable |
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193,200 |
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193,200 |
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Research and development obligation |
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606,950 |
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592,100 |
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Financial instrument |
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3,979,373 |
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2,859,596 |
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Total Current Liabilities |
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7,506,193 |
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6,547,515 |
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TOTAL LIABILITIES |
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7,506,193 |
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6,547,515 |
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STOCKHOLDERS DEFICIT |
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Preferred stock, Series A,
convertible; no par value; 42,000 shares authorized; 41,800 and
42,000 shares issued and outstanding, respectively; (aggregate liquidation preference of
$4,180,000 and $4,200,000, respectively) |
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514,612 |
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523,334 |
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Common stock, no par value; 250,000,000 shares authorized; 107,922,148 and 107,679,724
shares issued and outstanding, respectively |
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15,220,617 |
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15,211,895 |
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Additional paid-in capital |
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1,056,020 |
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988,670 |
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Deficit accumulated prior to the development stage |
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(1,399,577 |
) |
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|
(1,399,577 |
) |
Deficit accumulated during the development stage |
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|
(22,412,180 |
) |
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|
(20,840,714 |
) |
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|
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|
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Total Stockholders Deficit |
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(7,020,508 |
) |
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|
(5,516,392 |
) |
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TOTAL LIABILITIES AND STOCKHOLDERS DEFICIT |
|
$ |
485,685 |
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|
$ |
1,031,123 |
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See notes to condensed consolidated financial statements
- 4 -
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(Unaudited)
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From Inception |
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of the |
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Development Stage |
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For the Three |
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on November 20, 1991 |
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Months Ended |
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Through |
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March 31, |
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March 31, |
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2006 |
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2005 |
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2006 |
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REVENUES |
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$ |
|
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|
$ |
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|
$ |
157,044 |
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COST OF GOODS SOLD |
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14,564 |
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GROSS PROFIT |
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142,480 |
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OPERATING EXPENSES |
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General and administrative |
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|
345,520 |
|
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|
251,996 |
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|
|
17,400,517 |
|
Research and development |
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|
92,583 |
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|
|
1,551,986 |
|
|
|
5,813,782 |
|
Inventory write-down |
|
|
|
|
|
|
|
|
|
|
96,859 |
|
Impairment loss |
|
|
|
|
|
|
|
|
|
|
9,709 |
|
License fees |
|
|
|
|
|
|
|
|
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|
1,001,500 |
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|
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Total Expenses |
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|
438,103 |
|
|
|
1,803,982 |
|
|
|
24,322,367 |
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|
LOSS FROM OPERATIONS |
|
|
(438,103 |
) |
|
|
(1,803,982 |
) |
|
|
(24,179,887 |
) |
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OTHER INCOME (EXPENSES) |
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Unrealized gain (loss) on financial instrument |
|
|
(1,119,777 |
) |
|
|
(142,262 |
) |
|
|
1,180,414 |
|
Interest income |
|
|
1,211 |
|
|
|
5,564 |
|
|
|
56,509 |
|
Interest expense |
|
|
(7,372 |
) |
|
|
(15,898 |
) |
|
|
(1,163,073 |
) |
Foreign currency transaction gain (loss) |
|
|
(7,425 |
) |
|
|
19,900 |
|
|
|
49,055 |
|
Gain on forgiveness of debt |
|
|
|
|
|
|
|
|
|
|
1,431,889 |
|
Other income |
|
|
|
|
|
|
|
|
|
|
905,112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Total Other Income (Expenses) |
|
|
(1,133,363 |
) |
|
|
(132,696 |
) |
|
|
2,459,906 |
|
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|
|
|
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|
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|
NET LOSS |
|
|
(1,571,466 |
) |
|
|
(1,936,678 |
) |
|
|
(21,719,981 |
) |
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividend from
beneficial conversion feature |
|
|
|
|
|
|
|
|
|
|
(692,199 |
) |
|
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|
|
|
|
|
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|
|
|
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|
|
|
|
|
|
|
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|
|
NET LOSS APPLICABLE TO
COMMON SHAREHOLDERS |
|
$ |
(1,571,466 |
) |
|
$ |
(1,936,678 |
) |
|
$ |
(22,412,180 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
BASIC AND DILUTED LOSS PER
COMMON SHARE |
|
$ |
(0.01 |
) |
|
$ |
(0.02 |
) |
|
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|
|
|
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|
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|
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|
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|
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|
WEIGHTED AVERAGE NUMBER OF
SHARES OUTSTANDING |
|
|
107,895,212 |
|
|
|
106,506,793 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to condensed consolidated financial statements
- 5 -
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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|
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|
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|
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From Inception |
|
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|
For the Three |
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|
of the |
|
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|
Months Ended |
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|
Development Stage |
|
|
|
March 31, |
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|
on November 20, 1991 |
|
|
|
2006 |
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|
2005 |
|
|
Through March 31, 2006 |
|
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(1,571,466 |
) |
|
$ |
(1,936,678 |
) |
|
$ |
(21,719,981 |
) |
Adjustments to reconcile net loss to net cash used by operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency transaction (gain) loss |
|
|
7,425 |
|
|
|
(19,900 |
) |
|
|
(49,055 |
) |
Gain on debt restructuring |
|
|
|
|
|
|
|
|
|
|
(1,431,889 |
) |
Common stock issued for services |
|
|
|
|
|
|
18,750 |
|
|
|
4,267,717 |
|
Commitment for research and development obligation |
|
|
|
|
|
|
665,700 |
|
|
|
665,700 |
|
Unrealized (gain) loss on financial instrument |
|
|
1,119,777 |
|
|
|
142,262 |
|
|
|
(1,180,414 |
) |
Depreciation |
|
|
5,014 |
|
|
|
|
|
|
|
113,800 |
|
Reduction of escrow receivable from
research and development |
|
|
|
|
|
|
|
|
|
|
272,700 |
|
Stock options and warrants granted for services |
|
|
67,350 |
|
|
|
|
|
|
|
4,878,603 |
|
Reduction of legal costs |
|
|
|
|
|
|
|
|
|
|
(130,000 |
) |
Write-off of subscriptions receivable |
|
|
|
|
|
|
|
|
|
|
112,500 |
|
Impairment of loss on assets |
|
|
|
|
|
|
|
|
|
|
9,709 |
|
Loss on disposal of equipment |
|
|
|
|
|
|
|
|
|
|
30,364 |
|
Write-off of receivable |
|
|
|
|
|
|
|
|
|
|
245,065 |
|
Note payable issued for litigation |
|
|
|
|
|
|
|
|
|
|
385,000 |
|
Changes in operating assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in accounts receivable |
|
|
|
|
|
|
|
|
|
|
(7,529 |
) |
Increase (decrease) in accounts payable |
|
|
(183,321 |
) |
|
|
(84,904 |
) |
|
|
2,280,865 |
|
Increase in accrued expenses |
|
|
7,372 |
|
|
|
15,898 |
|
|
|
645,291 |
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used by Operating Activities |
|
|
(547,849 |
) |
|
|
(1,198,872 |
) |
|
|
(10,611,554 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Increase in deposits |
|
|
|
|
|
|
|
|
|
|
(51,100 |
) |
Purchase of equipment |
|
|
|
|
|
|
|
|
|
|
(221,334 |
) |
Issuance of note receivable |
|
|
|
|
|
|
|
|
|
|
(313,170 |
) |
Payments received on note receivable |
|
|
|
|
|
|
|
|
|
|
130,000 |
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used by Investing Activities |
|
|
|
|
|
|
|
|
|
|
(455,604 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock, preferred stock and warrants for cash |
|
|
|
|
|
|
2,902,000 |
|
|
|
10,033,845 |
|
Contributed equity |
|
|
|
|
|
|
|
|
|
|
131,374 |
|
Proceeds from notes payable |
|
|
|
|
|
|
|
|
|
|
1,336,613 |
|
Payments on notes payable |
|
|
|
|
|
|
|
|
|
|
(801,287 |
) |
Proceeds from convertible notes payable |
|
|
|
|
|
|
|
|
|
|
571,702 |
|
Payments on convertible notes payable |
|
|
|
|
|
|
|
|
|
|
(98,500 |
) |
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by Financing Activities |
|
|
|
|
|
|
2,902,000 |
|
|
|
11,173,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH |
|
|
(547,849 |
) |
|
|
1,703,128 |
|
|
|
106,589 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AT BEGINNING OF PERIOD |
|
|
654,438 |
|
|
|
1,455,397 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AT END OF PERIOD |
|
$ |
106,589 |
|
|
$ |
3,158,525 |
|
|
$ |
106,589 |
|
|
|
|
|
|
|
|
|
|
|
See notes to condensed consolidated financial statements
- 6 -
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Condensed Consolidated Statements of Cash Flows (Continued)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
For the Three |
|
|
|
Months Ended |
|
|
|
March 31, |
|
|
|
2006 |
|
|
2005 |
|
SUPPLEMENTAL DISCLOSURES OF
CASH FLOW INFORMATION |
|
|
|
|
|
|
|
|
Initial valuation of financial instrument |
|
$ |
|
|
|
$ |
6,279,829 |
|
Conversion of preferred stock to common stock |
|
$ |
8,722 |
|
|
$ |
|
|
See notes to condensed consolidated financial statements
- 7 -
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to the Unaudited Condensed Consolidated Financial Statements
Note 1 Basis of Presentation
Unaudited Interim Consolidated Financial Statements
The accompanying unaudited consolidated financial statements have been prepared by the Company
pursuant to the rules and regulations of the Securities and Exchange Commission. Certain
information and footnote disclosures normally included in financial statements prepared in
accordance with generally accepted accounting principles have been condensed or omitted pursuant to
such rules and regulations. In the opinion of management, all adjustments and disclosures necessary
for a fair presentation of these financial statements have been included. These financial
statements should be read in conjunction with the financial statements and notes thereto included
in the Companys 2005 Annual Report on Form 10-KSB for the year ended December 31, 2005, as filed
with the Securities and Exchange Commission. Certain reclassifications and other corrections for
rounding have been made in prior-period financial statements to conform to the current-period
presentation. The consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries. All significant intercompany transactions and balances have been
eliminated in consolidation.
Loss Per Common Share
Loss per share is computed by dividing net loss applicable to common shareholders by the
weighted-average number of shares outstanding. Potential common shares from convertible notes
payable, warrants and stock options have not been included as they are anti-dilutive.
Stock Based Compensation and Restatement
Effective January 1, 2006 the Company adopted SFAS No. 123(R), Share-Based Payments (FAS
123(R)), an amendment of SFAS No. 123, Accounting for Stock Based Compensation, using the
modified prospective transition method. Under this transaction method, compensation cost is
recognized beginning with the effective date: (a) based on the requirements of FAS 123(R) for all
share-based awards granted after the effective date and (b) based on the requirements of FAS 123
for all awards granted to employees prior to the effective date of FAS 123(R) that remain unvested
on the effective date. Accordingly, we did not restate the results of prior periods. The most
notable change with the adoption is that compensation expense associated with stock options is now
recognized in our Consolidated Statement of Operations, rather than being disclosed in pro forma
footnote to our consolidated financial statements.
Prior to January 1, 2006, the Company accounted for stock options issued to directors, officers,
and employees under Accounting Principals Board Opinion No. 25 and related interpretations (APB
25). The Company accounted for options and warrants issued to non-employees at their fair value
in accordance with SFAS 123, Accounting for Stock-Based Compensation (SFAS 123). Share-based
compensation was included as a pro forma disclosure in the financial statement footnotes for
periods prior to January 1, 2006. The Company did not have any employee based options that vested
during 2005.
As a result of adopting FAS 123(R), we recognized compensation expense related to options granted
during the three months ended March 31, 2006 in the amount of $67,350, which was the fair value of
the options issued during the three months ended March 31, 2006.
- 8 -
Note 2 Going Concern Considerations
The Companys recurring losses from development-stage activities in current and prior years raise
substantial doubt about the Companys ability to continue as a going concern. The financial
statements do not include any adjustments to reflect the possible effects on the recoverability and
classification of assets or amounts and classifications of liabilities that may result from the
possible inability of the Company to continue as a going concern. The Company is attempting to
raise additional capital to fund research and development costs until it is able to consistently
generate revenues and sustain profitable operations. However, there can be no assurance that these
plans will be successful.
Note 3 Preferred Stock, Financial Instrument, and Options
During the three months ended March 31, 2005, the Company converted 200 shares of Series A
Preferred Stock into 242,424 shares Common Stock pursuant to the Subscription Agreement dated
October 18, 2004. The conversion price was $.0825 per share.
The Company adjusted to market value the outstanding warrants as of March 31, 2006. The fair value
of the financial instrument was $3,979,373. The Company used the Black Scholes model in
calculating fair value with the following assumptions: volatility of 147%, risk-free interest rate
of 4.82%, and an expected life of two years. The changes in fair market value have been recorded
as adjustments in the line Unrealized gain (loss) on financial instrument in the financial
statements.
During the three months ended March 31, 2006, the Company granted a stock option to a former
officer and director. The option is for 500,000 shares exercisable at
$0.25 per share through December 31, 2010. The Company valued these options at
$67,350 ($0.13 per share) using the Black-Scholes option pricing model with the following
assumptions: risk-free rate of 4.3%, volatility of 152%, and an expected life of five years.
Note 4 Related Party Transactions
At March 31, 2006, the Company had accounts payable to current and former officers and directors
totaling $1,539,586, respectively, for services performed and costs incurred in behalf of the
Company, including $877,636 payable to the Companys President and CEO. Also at March 31, 2006, the
Company had accounts payable to its controller of $73,000.
On July 15, 2005, the Company entered into an agreement to grant a consultant a non-interest
bearing loan in the amount of 500,000 (approximately $607,000 under current exchange rates) in
exchange for the transfer of certain patents in relation to Savetherapeutics AG, and the
performance of certain research activities. The loan is payable as follows, 100,000 upon
closing, 150,000 after signature of consent to the transfer of patents, and 250,000 after
performance and acceptance of certain research activities. As of March 31, 2006, the amount of the
loan was 250,000 (approximately $303,000 under current exchange rates). Settlement of the loan
shall take place by offsetting against profit claims, which accrue to the consultant from his stake
in the Company.
Subsequent to the transfer of the industrial property rights and applications, the Company shall
grant to the aforementioned consultant a 6% stake in MDI Oncology, Inc. and to assign to him 6% of
the shares. The Company deemed these shares to have no value because it is a start-up company, and
its success is contingent on several different factors. The Company also entered into an employment
contract with the consultant for a period of 24 months. The shareholder will receive a fee of
120,000 per annum (approximately $146,000 using current exchange rates).
- 9 -
Note 5 Other Significant Transactions
SaveCream Asset Purchase
On March 16, 2005, the Company completed the purchase of the intellectual property assets (the
Assets) of Savetherapeutics AG, a German corporation in liquidation in Hamburg, Germany
(SaveT). The Assets consist primarily of patents, patent applications, pre-clinical study data
and clinical trial data concerning SaveCream, SaveTs developmental-stage topical aromatase
inhibitor treatment for breast cancer. SaveCream never generated revenues for SaveT. The Companys
analysis as to whether the intellectual property purchased constituted a business resulted in the
conclusion that no such business had been acquired.
The purchase price of the Assets was 2,350,000 (approximately $2.8 million under current
exchange rates), payable as follows: 500,000 at closing, 500,000 (approximately $665,700 on
the date of transaction, $607,000 using the March 31, 2006 exchange rates) upon conclusion of
certain pending transfers of patent and patent application rights from SaveTs inventors to the
Company, and the remaining 1,350,000 (approximately $1.6 million at current exchange rates)
upon successful commercialization of the Assets. The Companys source of funds for the acquisition
was a $3 million investment in the Companys Series A Preferred Stock by an unrelated third party.
SaveT inventors have yet to fully assign the patent and application rights to the Company, but
management has deemed the assignment of the rights to be reasonably likely because the inventors
are contractually bound to execute and deliver the assignments; therefore, the Company has recorded
the second 500,000 payment as a current liability in these financial statements. At present it
is undeterminable whether the intellectual property will ever be commercialized; therefore, the
final 1,350,000 under this acquisition has not been accrued as a liability as of March 31,
2006. The Company determined the intellectual property purchased should be expensed as research and
development costs.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The purpose of this section is to discuss and analyze our condensed consolidated financial
condition, liquidity and capital resources, and results of operations. This analysis should be read
in conjunction with the condensed consolidated financial statements and notes thereto at pages 3
through 10 and Managements Discussion and Analysis of Financial Condition and Results of
Operations contained in our Annual Report on Form 10-KSB for the year ended December 31, 2005 (the
2005 10-KSB).
This section contains certain forward-looking statements that involve risks and uncertainties,
including statements regarding our plans, objectives, goals, strategies and financial performance.
Our actual results could differ materially from the results anticipated in these forward-looking
statements as a result of factors set forth under Cautionary Statement for Forward-Looking
Information and Factors Affecting Future Results below and elsewhere in this report.
Overview
We are a developmental-stage bio-pharmaceutical company engaged in the research, validation,
development and ultimate commercialization of two drugs: MDI-P and SaveCream. MDI-P is an
anti-infective drug that we believe will be a useful and well-tolerated treatment for bacterial
infections, viral infections and fungal infections. We further believe that MDI-P will be a useful
treatment for cystic fibrosis. SaveCream is a breast cancer medication that is applied topically to
reduce breast cancer tumors. Both of these drugs are still in development and have not been
approved by the U. S. Food and Drug Administration (FDA).
- 10 -
Our initial target indications for MDI-P are cystic fibrosis and HIV. On November 10, 2004 we filed
an Investigational New Drug application (IND) with the FDA seeking permission to begin Phase I
human clinical trials of MDI-P as a treatment for cystic fibrosis. The FDA placed the proposed
Phase I clinical trials on clinical hold
pending additional preclinical testing. We completed that preclinical testing and no significant
toxicities were noted. We submitted that data to the FDA on March 16, 2006. On April 21, 2006,
the FDA responded and continued the clinical hold pending the outcome of yet another battery of
preclinical trials. We intend to complete those additional tests and resubmit our IND within 6
months of raising additional capital to fund those tests. If the FDA lifts the clinical hold upon
receipt of the amended IND and allows us to proceed with Phase I studies, we will begin human
trials at St. Lukes Regional Medical Center in Boise, Idaho using a protocol designed by Dr. Henry
Thompson. If our Phase I IND for cystic fibrosis is successful, we intend to file an IND for Phase
I testing of MDI-P as a treatment for HIV at Harvard School of Medicine using a protocol designed
by Dr. Bruce Dezube. We also expect to add additional indications for the use of MDI-P in the
future as we further our preclinical development.
We recently purchased SaveCream from a German biotechnology company. We are in the process of
developing a global commercialization strategy for SaveCream.
To date, we have not generated significant revenues from operations or realized a profit. Through
March 31, 2006, we had incurred cumulative net losses since inception of $22,412,180.
Recent Events
Cystic Fibrosis IND. We are continuing to prosecute our IND for cystic fibrosis with the FDA. We
submitted an amended IND to the FDA on March 16, 2006. On April 21, 2006, the FDA responded and
continued the clinical hold pending the outcome of yet another battery of preclinical trials.
Specifically, the FDA has suggested we conduct two additional toxicity studies (dose response and
acute toxicity) in a third mammal species, the rat. Data from those studies will help establish
safe dosing in humans. In addition, the FDA has asked for additional data on the extractable
components of MDI-P.
The additional studies and data the FDA is requesting can be completed within six months time.
However, we will need additional capital to conduct the studies. We estimate the cost of the
studies plus overhead expenses during the period of study to require an aggregate of $1 million in
funding.
Results of Operations
Revenues and Gross Profit We did not book any revenue for the quarters ended March 31, 2006 or
March 31, 2005. As we continue to pursue preclinical and clinical testing of our pharmaceuticals,
we may not book significant revenues in the near future.
Operating Expenses and Operating Loss We incurred $92,583 in research and development expenses
for the quarter ended March 31, 2006. We incurred $1,551,986 in research and development expenses
for the same period of 2005. Our general and administrative expenses were $345,520 during the
quarter ended March 31, 2006, as compared to $251,996 during the quarter ended March 31, 2005. As a
result of the foregoing, we sustained an operating loss of $438,103 for the quarter ended March 31,
2006, as compared with an operating loss of $1,803,982 for the same period of 2005.
Other Income/Expense and Net Loss We booked $1,211 in interest income and incurred interest
expenses of $7,372 for the quarter ended March 31, 2006, as compared with interest income of $5,564
and $15,898 in interest expenses for the same period of 2005. During the quarter ended March 31,
2006, we also booked a foreign currency loss of $7,425. We had a foreign currency gain of 19,900
for the same period of 2005. In addition, we recorded $1,119,977 as unrealized loss on financial
instrument during the quarter ended March 31, 2006 to record the accounting of warrants resulting
from the issuance of the Series A Convertible Preferred Stock entered into in October 2004 and
March 2005. The unrealized loss on financial instrument was $142,262 for the same period of 2005.
In sum, our net loss applicable to common shareholders for the first quarter of 2006 was $1,571,466
or a loss of $0.01 per fully diluted share. For the quarter ended March 31, 2005 we incurred a net
loss applicable to common shareholders of $1,936,678, making a loss of less than $0.01 per fully
diluted share.
- 11 -
Future Expectations We may operate at a loss for several more years while we continue to
research, gain regulatory approval of, and commercialize our technologies. As funding is available,
we will spend more in the remainder of the 2006 fiscal year in research and development expenses
than we did over the prior year as we
continue to implement our commercialization strategy. Similarly, we expect our general and
administrative expenses to continue to increase for the remainder of 2006 as we continue to expand
the scope of our operations. As a result, we expect to sustain a greater net loss in 2006 than we
have in recent years.
Liquidity and Capital Resources - As of March 31, 2006, we had $106,589 in cash and had a working
capital deficit of $7,020,508. Since our inception, we have financed our operations primarily
through private sales of equity and the issuance of convertible and non-convertible notes. We
continue to require significant supplementary funding to continue to develop, research, and seek
regulatory approval of our technologies. We do not currently generate any cash from operations and
have no credit facilities in place or available. Currently, we are funding operations through
private issuances of equity.
Given that we are still in an early development stage and do not have revenues from operations,
raising equity financing is difficult. In addition, any additional equity financing will have a
substantial dilutive effect to our current shareholders.
We estimate we will need approximately $1 million in capital in order to advance MDI-P to the next
developmental milestone: approval of our Phase I IND. If our IND application is approved, we will
need additional capital to initiate Phase I clinical trials. We estimate the cost to complete Phase
I and Phase II clinical trials to be several million dollars per indication and the cost to
complete Phase III testing and obtain approval to market to be in the tens of millions of dollars
per indication. While our ability to obtain financing may improve in the event an IND application
is approved and we enter the clinic, we cannot give assurances that we will have access to the
significant capital required to take a drug through regulatory approvals and to market. We may seek
a partner in the global pharmaceutical industry to help us co-develop, license, or even purchase
some or all of our technologies.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements as defined in Item 303(c) of Regulation S-B.
Cautionary Statement for Forward Looking Information
Certain information set forth in this report contains forward-looking statements within the
meaning of federal securities laws. Forward looking statements include statements concerning our
plans, objectives, goals, strategies, future events, future revenues or performance, capital
expenditures, and financing needs and other information that is not historical information. When
used in this report, the words estimates, expects, anticipates, forecasts, plans,
intends, believes and variations of such words or similar expressions are intended to identify
forward-looking statements. Additional forward-looking statements may be made by us from time to
time. All such subsequent forward-looking statements, whether written or oral and whether made by
us or on our behalf, are also expressly qualified by these cautionary statements.
Our forward-looking statements are based upon our current expectations and various assumptions. Our
expectations, beliefs and projections are expressed in good faith and are believed by us to have a
reasonable basis, including without limitation, our examination of historical operating trends,
data contained in our records and other data available from third parties, but there can be no
assurance that our expectations, beliefs and projections will result or be achieved or
accomplished. Our forward-looking statements apply only as of the date made. We undertake no
obligation to publicly update or revise forward-looking statements which may be made to reflect
events or circumstances after the date made or to reflect the occurrence of unanticipated events.
- 12 -
There are a number of risks and uncertainties that could cause actual results to differ materially
from those set forth in, contemplated by or underlying the forward-looking statements contained in
this report. Those risks and uncertainties include, but are not limited to, our lack of significant
operating revenues and lack of profit to date, our need for substantial and immediate additional
capital, the fact that we may dilute existing shareholders through additional stock issuances, the
extensive governmental regulation to which we are subject, the fact that our technologies remain
unproven, the intense competition we face from other companies and other products, and our reliance
upon potentially inadequate intellectual property. Those risks and certain other uncertainties are
discussed in more detail in the 2005 10-KSB. There may also be other factors, including those
discussed elsewhere in this
report, that may cause our actual results to differ from the forward-looking statements. Any
forward-looking statements made by us or on our behalf should be considered in light of these
factors.
ITEM 3. CONTROLS AND PROCEDURES
(a) Under the supervision and with the participation of our management, including our principal
executive officer and principal financial officer, we conducted an evaluation of our disclosure
controls and procedures, as such term is defined under Rule 13a-14(c) promulgated under the
Securities Exchange Act of 1934, as amended (the Exchange Act), as of March 31, 2006. Based on
this evaluation, our principal executive officer and principal financial officer concluded that our
disclosure controls and procedures were effective as of March 31, 2006.
(b) There have been no significant changes (including corrective actions with regard to significant
deficiencies or material weaknesses) in our internal controls or in other factors that could
significantly affect these controls subsequent to the date of the evaluation referenced in
paragraph (a) above.
- 13 -
PART II
OTHER INFORMATION
ITEM 6. EXHIBITS
The following documents are furnished as exhibits to this Form 10-QSB. Exhibits marked with an
asterisk are filed herewith. The remainder of the exhibits previously have been filed with the
Commission and are incorporated herein by reference.
|
|
|
Number |
|
Exhibit |
2.1
|
|
Sale and Purchase Agreement between Attorney
Hinnerk-Joachim Müller as liquidator of
Savetherapeutics AG i.L. and Medical
Discoveries, Inc. regarding the purchase of the
essential assets of Savetherapeutics AG i.L.
(filed as Exhibit 2.1 to the Companys Annual
Report on Form 10-KSB for the fiscal year ended
December 31, 2004, and incorporated herein by
reference). |
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|
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3.1
|
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Amended and Restated Articles of Incorporation
of the Company (filed as Exhibit 3.1 to the
Companys Annual Report on Form 10-KSB for the
fiscal year ended December 31, 1994, and
incorporated herein by reference). |
|
|
|
3.2
|
|
Amended Bylaws of the Company (filed as Exhibit
3.2 to the Companys Annual Report on Form
10-KSB for the fiscal year ended December 31,
1994, and incorporated herein by reference). |
|
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|
4.1
|
|
Registration Rights Agreement dated October 18,
2004 among Monarch Pointe Fund, Ltd., Mercator
Advisory Group, LLC and Medical Discoveries,
Inc. (filed as Exhibit 4.1 to the
Companys Annual Report on Form 10-KSB for the
fiscal year ended December 31, 2004, and
incorporated herein by reference). |
|
|
|
4.2
|
|
Registration Rights Agreement dated December 3,
2004 among Mercator Momentum Fund, LP, Mercator
Momentum Fund III, LP, Mercator Advisory Group,
LLC and Medical Discoveries, Inc.
(filed as Exhibit 4.2 to the Companys
Annual Report on Form 10-KSB for the fiscal year
ended December 31, 2004, and incorporated herein
by reference). |
|
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4.3
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Certificate of Designations of Preferences and
Rights of Series A Convertible Preferred Stock
of Medical Discoveries, Inc. (filed as Exhibit
4.1 to Registration Statement No. 333-121635
filed on Form SB-2 on December 23, 2004, and
incorporated herein by reference). |
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4.4
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|
Amendment to Certificate of Designations of
Preferences and Rights of Series A Convertible
Preferred Stock of Medical Discoveries, Inc.
(filed as Exhibit 4.2 to Registration Statement
No. 333-121635 filed on Form SB-2 on December
23, 2004, and incorporated herein by reference). |
|
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|
10.1
|
|
2002 Stock Incentive Plan adopted by the Board
of Directors as of July 11, 2002 (filed as
Exhibit 10.5 to the Companys Quarterly Report
on Form 10-QSB for the quarter ended June 30,
2002, and incorporated herein by reference). |
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10.2
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Subscription Agreement dated October 18, 2004
among Monarch Pointe Fund, Ltd., Mercator
Advisory Group, LLC, and Medical Discoveries,
Inc. (filed as Exhibit 10.2 to Amendment No. 2
to Registration Statement No. 333-121635 filed
on form SB-2 on June 2, 2005, and incorporated
herein by reference). |
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10.3
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Subscription Agreement dated December 3, 2004
among Mercator Momentum Fund, LP, Mercator
Momentum Fund III, LP, Mercator Advisory Group,
LLC, and Medical Discoveries, Inc. (filed as
Exhibit 10.3 to Amendment No. 2 to Registration
Statement No. |
- 14 -
|
|
|
Number |
|
Exhibit |
|
|
333-121635 filed on form SB-2 on
June 2, 2005, and incorporated herein by
reference). |
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10.4
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Employment Agreement dated March 1, 2005 between
Medical Discoveries, Inc. and Judy M. Robinett.
(filed as Exhibit 10.4 to Amendment No. 3 to
Registration Statement No. 333-121635 filed on
Form SB-2 on October 13, 2005, and incorporated
herein by reference). |
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21
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Subsidiaries.* |
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31.1
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Rule 13a-14(a) Certification, as adopted
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.* |
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31.2
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Rule 13a-14(a) Certification, as adopted
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.* |
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32.1
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|
Certification pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.* |
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32.2
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|
Certification pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.* |
- 15 -
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
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MEDICAL DISCOVERIES, INC. |
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/S/ JUDY M. ROBINETT |
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Judy M. Robinett |
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Date: May 15, 2006
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President and Chief Executive Officer |
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- 16 -
INDEX TO EXHIBITS
|
|
|
Number |
|
Exhibit |
2.1
|
|
Sale and Purchase Agreement between Attorney
Hinnerk-Joachim Müller as liquidator of
Savetherapeutics AG i.L. and Medical
Discoveries, Inc. regarding the purchase of the
essential assets of Savetherapeutics AG i.L.
(filed as Exhibit 2.1 to the Companys Annual
Report on Form 10-KSB for the fiscal year ended
December 31, 2004, and incorporated herein by
reference). |
|
|
|
3.1
|
|
Amended and Restated Articles of Incorporation
of the Company (filed as Exhibit 3.1 to the
Companys Annual Report on Form 10-KSB for the
fiscal year ended December 31, 1994, and
incorporated herein by reference). |
|
|
|
3.2
|
|
Amended Bylaws of the Company (filed as Exhibit
3.2 to the Companys Annual Report on Form
10-KSB for the fiscal year ended December 31,
1994, and incorporated herein by reference). |
|
|
|
4.1
|
|
Registration Rights Agreement dated October 18,
2004 among Monarch Pointe Fund, Ltd., Mercator
Advisory Group, LLC and Medical Discoveries,
Inc. (filed as Exhibit 4.1 to the
Companys Annual Report on Form 10-KSB for the
fiscal year ended December 31, 2004, and
incorporated herein by reference). |
|
|
|
4.2
|
|
Registration Rights Agreement dated December 3,
2004 among Mercator Momentum Fund, LP, Mercator
Momentum Fund III, LP, Mercator Advisory Group,
LLC and Medical Discoveries, Inc.
(filed as Exhibit 4.2 to the Companys
Annual Report on Form 10-KSB for the fiscal year
ended December 31, 2004, and incorporated herein
by reference). |
|
|
|
4.3
|
|
Certificate of Designations of Preferences and
Rights of Series A Convertible Preferred Stock
of Medical Discoveries, Inc. (filed as Exhibit
4.1 to Registration Statement No. 333-121635
filed on Form SB-2 on December 23, 2004, and
incorporated herein by reference). |
|
|
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4.4
|
|
Amendment to Certificate of Designations of
Preferences and Rights of Series A Convertible
Preferred Stock of Medical Discoveries, Inc.
(filed as Exhibit 4.2 to Registration Statement
No. 333-121635 filed on Form SB-2 on December
23, 2004, and incorporated herein by reference). |
|
|
|
10.1
|
|
2002 Stock Incentive Plan adopted by the Board
of Directors as of July 11, 2002 (filed as
Exhibit 10.5 to the Companys Quarterly Report
on Form 10-QSB for the quarter ended June 30,
2002, and incorporated herein by reference). |
|
|
|
10.2
|
|
Subscription Agreement dated October 18, 2004
among Monarch Pointe Fund, Ltd., Mercator
Advisory Group, LLC, and Medical Discoveries,
Inc. (filed as Exhibit 10.2 to Amendment No. 2
to Registration Statement No. 333-121635 filed
on form SB-2 on June 2, 2005, and incorporated
herein by reference). |
|
|
|
10.3
|
|
Subscription Agreement dated December 3, 2004
among Mercator Momentum Fund, LP, Mercator
Momentum Fund III, LP, Mercator Advisory Group,
LLC, and Medical Discoveries, Inc. (filed as
Exhibit 10.3 to Amendment No. 2 to Registration
Statement No. 333-121635 filed on form SB-2 on
June 2, 2005, and incorporated herein by
reference). |
|
|
|
10.4
|
|
Employment Agreement dated March 1, 2005 between
Medical Discoveries, Inc. and Judy M. Robinett.
(filed as Exhibit 10.4 to Amendment No. 3 to
Registration Statement No. 333-121635 filed on
Form SB-2 on October 13, 2005, and incorporated
herein by reference). |
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|
|
21
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|
Subsidiaries.* |
- 17 -
|
|
|
Number |
|
Exhibit |
31.1
|
|
Rule 13a-14(a) Certification, as adopted
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.* |
|
|
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31.2
|
|
Rule 13a-14(a) Certification, as adopted
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.* |
|
|
|
32.1
|
|
Certification pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.* |
|
|
|
32.2
|
|
Certification pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.* |
- 18 -